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Dignity Therapy in mCRC to Increase Peaceful Awareness & Impact Goals of Care Decision-Making

Primary Purpose

Stage IV Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dignity Therapy
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stage IV Colorectal Cancer focused on measuring Stage IV Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • Participants must be currently receiving treatment for stage IV colorectal cancer.
  • Participants must have experience disease progression after their first course of treatment and are being considered for second course of treatment or have already started their second course of treatment.
  • Participants must be 18 years old or older.
  • All participants must have given signed, informed consent prior to registration on study.
  • Participants must speak English.

Sites / Locations

  • Northwestern University, Northwestern Memorial Faculty Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Immediate Dignity Therapy

Wait List Dignity Therapy

Arm Description

At registration, subjects will be mailed a questionnaire. The subject will then receive two separate dignity therapy sessions, about a week apart. Subjects will then be asked to complete a questionnaire 1-2 weeks after completing therapy sessions and one month after completing therapy sessions.

At registration, subjects will be mailed a questionnaire. The subject will then receive two separate dignity therapy sessions; the first session will take place about 6 weeks after registration, with the second session occurring 1-3 weeks after the first. Subjects will then be asked to complete a questionnaire about one month after completing therapy sessions.

Outcomes

Primary Outcome Measures

Impact of Dignity Therapy
Measure the impact of dignity therapy on terminal illness acknowledgment and presence of peaceful awareness. Subjects will complete self-evaluation questionnaires at the point of registration and upon completing dignity therapy sessions. The impact will be determined by changes in the patient's baseline self-reported parameters.

Secondary Outcome Measures

Measure the impact of dignity therapy on life sustaining therapy and end-of-life goals of care.
Subjects will complete self-evaluation questionnaires at the point of registration and upon completing dignity therapy sessions. The impact will be determined by changes in the patient's baseline self-reported parameters.
Establish a correlation between terminal illness acknowledgement and presence of peaceful awareness with preferences for life sustaining therapy and end-of-life goals of care.
Establish a correlation between terminal illness acknowledgement and presence of peaceful awareness with preferences for life sustaining therapy and end-of-life goals of care.

Full Information

First Posted
February 22, 2010
Last Updated
September 13, 2013
Sponsor
Northwestern University
Collaborators
Robert H. Lurie Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01074385
Brief Title
Dignity Therapy in mCRC to Increase Peaceful Awareness & Impact Goals of Care Decision-Making
Official Title
Use of Dignity Therapy in Stage IV Colorectal Cancer Patients Receiving Chemotherapy to Increase Peaceful Awareness and Impact Goals of Care Decision-Making
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
Robert H. Lurie Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to try and improve the way that patients with colon cancer understand and cope with their illness and give them tools for talking with their loved ones and family about their illness.
Detailed Description
Dignity Therapy is a well tolerated structured interview that helps patients reflect on who they are, what is most important to them and what lessons they have learned through life. For patients not receiving chemotherapy, Dignity Therapy gave patients more hope, more meaning in their life, and helped their families. Researchers at Northwestern University would like to see if it has the same effect in patients getting chemotherapy. We will also see if the Dignity Therapy changes patient's understanding of their disease and their medical preferences. All study procedures will take place when participants come for a scheduled doctor's visit or to receive chemotherapy. At the first visit participants will answer a questionnaire taking approximately 15-30 minutes. Participants will then have a Dignity Therapy Session approximately 1-2 weeks later. A second Dignity Therapy Session will be scheduled again in another 1-2 weeks. Each study Dignity Therapy Session will take approximately an hour. One to two weeks later a repeat questionnaire will be filled out. Finally, a third and final questionnaire will be complete 4 weeks later.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Colorectal Cancer
Keywords
Stage IV Colorectal Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Dignity Therapy
Arm Type
Other
Arm Description
At registration, subjects will be mailed a questionnaire. The subject will then receive two separate dignity therapy sessions, about a week apart. Subjects will then be asked to complete a questionnaire 1-2 weeks after completing therapy sessions and one month after completing therapy sessions.
Arm Title
Wait List Dignity Therapy
Arm Type
Other
Arm Description
At registration, subjects will be mailed a questionnaire. The subject will then receive two separate dignity therapy sessions; the first session will take place about 6 weeks after registration, with the second session occurring 1-3 weeks after the first. Subjects will then be asked to complete a questionnaire about one month after completing therapy sessions.
Intervention Type
Behavioral
Intervention Name(s)
Dignity Therapy
Intervention Description
Dignity therapy is a psychotherapeutic intervention developed to address psychosocial and existential distress among terminally ill patients. Basically, it invites patients to discuss topics that matter most or how they want to be remembered. This interview is recorded and then edited and returned to the patient to be used for further reflection or for sharing with loved ones.
Primary Outcome Measure Information:
Title
Impact of Dignity Therapy
Description
Measure the impact of dignity therapy on terminal illness acknowledgment and presence of peaceful awareness. Subjects will complete self-evaluation questionnaires at the point of registration and upon completing dignity therapy sessions. The impact will be determined by changes in the patient's baseline self-reported parameters.
Time Frame
at baseline, 1-2 weeks after completion of dignity therapy sessions, 1 month after completion of sessions
Secondary Outcome Measure Information:
Title
Measure the impact of dignity therapy on life sustaining therapy and end-of-life goals of care.
Description
Subjects will complete self-evaluation questionnaires at the point of registration and upon completing dignity therapy sessions. The impact will be determined by changes in the patient's baseline self-reported parameters.
Time Frame
at baseline, 1-2 weeks after completion of dignity therapy sessions, 1 month after completion of dignity therapy sessions
Title
Establish a correlation between terminal illness acknowledgement and presence of peaceful awareness with preferences for life sustaining therapy and end-of-life goals of care.
Description
Establish a correlation between terminal illness acknowledgement and presence of peaceful awareness with preferences for life sustaining therapy and end-of-life goals of care.
Time Frame
At Study Completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Participants must be currently receiving treatment for stage IV colorectal cancer. Participants must have experience disease progression after their first course of treatment and are being considered for second course of treatment or have already started their second course of treatment. Participants must be 18 years old or older. All participants must have given signed, informed consent prior to registration on study. Participants must speak English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Emanuel, MD, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University, Northwestern Memorial Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Dignity Therapy in mCRC to Increase Peaceful Awareness & Impact Goals of Care Decision-Making

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